New ISO Guide Offers Quality Management Aid to Medical Device Manufacturers

Significant quality systems and product requirements must be satisfied by manufacturers to ensure their medical devices produced are fit for their intended purpose, ISO notes, recognizing the wide range of medical devices -- everything from simple bandages to the most sophisticated radiotherapy equipment and software for disease screening.

The medical devices industry, one of the world's most-regulated sectors, has a new resource to tap in implementing and maintaining a quality management system. ISO recently released a new handbook named "ISO 13485:2016 – Medical devices – A practical guide," which was written by a group of technical experts from ISO's technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. It gives users practical guidance and accurate interpretation of the requirements specified in the ISO 13485:2016, standard.

Significant quality systems and product requirements must be satisfied by manufacturers to ensure their medical devices produced are fit for their intended purpose, ISO notes, recognizing the wide range of medical devices -- everything from simple bandages and tongue depressors to the most sophisticated radiotherapy equipment, implants, and software for disease screening.

"Implementing a quality management system that maintains the effectiveness of its processes and meeting applicable regulatory requirements can be challenging for the sector. Organizations may be treading on the finest of lines between distributing safe and effective medical devices quickly to the market, gaining the trust of customers and meeting regulatory requirements," the organization noted.

The handbook is mapped to the structure of the ISO 13485:2016 standard and offers step-by-step guidance for all organizations in the medical devices sector wishing to implement and maintain a quality management system. It is available for purchase through the ISO Store.

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